The currently valid List of vital and essential medicines has been approved by the Russian Government Decree No. 2199-R of 7 December 2011 and has not been revised in 2013. The new List of vital and essential medicines (developed as part of the Drug provision strategy for the Russian citizens up to 2025, as approved by the Ministry of Healthcare) will be made known to the public in the middle of November.
In particular, the Russian Ministry for Industry and Trade is developing a draft resolution, which provides for special procedures for purchasing medical goods and devices – including those subject to localization agreements aimed at bringing technological and economic benefits to the Russian Federation.
Regions may be authorized to purchase drugs under the 7 Diseases programme from 2015, and not in 2014 as had been planned earlier. Respective amendments have been made to the second reading of the draft law “On Amending Certain Legislative Acts of the Russian Federation in Relation to Public Health Issues in the Russian Federation”.
Keeping things centralized will have its advantages: in particular, participation in auctions may become more predictable and simple from a logistical perspective.
In accordance with the Presidential Decree “On Improving the State Policy for Public Health”, the Government, regional state bodies, the professional community and voluntary organizations have been assigned a number of tasks. One of these is to develop a strategy to supply drugs to the citizens up until 2025 and a plan for implementing this strategy.
The Strategy is supposed to clearly stipulate supply of drugs for all socially vulnerable groups: pensioners, the disabled, children, people with severe incurable diseases, in particular oncological and orphan diseases, and to set out the procedures for providing medicines for diagnostic purposes.
In addition, according to the Association of Russian Pharmaceutical Manufacturers, above all it is necessary to create a complete legal framework, starting with federal laws and ending with sub-law regulations, thereby eliminating a lack of coordination between various state departments. Thus the Russian pharmaceutical producers are to be given certain privileges; however, it still remains uncertain, which companies and products would qualify for local ones.
On 22 October 2013 the Federal Law No. 200-FL of 23 July 2013 “On Amending the Federal Law “On Advertising” and Article 14.3 of the Code of Administrative Offences” came into force, which increased the penalties for advertising violations in relation to drugs and dietary supplements.
Under the amended law, any advertising of dietary supplements should contain a warning that the subject of advertising is not a drug. In addition, it is the first time when the said law was supplemented by a provision establishing liability not only for advertisers, but also for the distributors of advertisements (see KPMG Pharma-Bulletin, Issue 7, 2013).
A commission may be set up in the Russian Government to establish a list of drugs whose public procurement will be done based on trade names. A respective draft law was published on 17 October 2013 by the Ministry of Healthcare.
Representatives from the FAS, the Ministry of Healthcare and the Ministry for Industry and Trade will approve the list. Creating the special governmental commission will help selecting the drugs to be included into the list more comprehensively; the medical community representatives will also be involved. According to the text of the draft Resolution, amendments to the final list of drugs (which will be approved by the Government) can be made at the request of any person or entity (see KPMG Pharma-Bulletin, Issue 8, 2013).
The validity period for registration certificates for medical devices and medical equipment of indefinite operation has been extended to 1 January 2017. The respective Decree No. 930 dated 17 October 2013 has been signed by Prime Minister Dmitry Medvedev.
The said Decree was drafted following numerous requests from the business community on the need for extending the registration certificates replacement period.
The need for these changes arose from the issue of VAT exemption availability for sales of the most important and vital medical equipment, as provided for by the Russian Tax Code (see KPMG Pharma-Bulletin, Issue 7, 2013).
The main objective of creating the public councils is to consider issues related to 1) establishing an independent system for assessing the quality of health care organizations, 2) developing changes to the Federal Law "On Circulation of Pharmaceuticals", and 3) discussing the operating plans of the Ministry of Healthcare of Russia until 2018.
It is also supposed that the Public Council under the Ministry of Healthcare should discuss the regulations drafted by the Ministry. In addition, it will carry out the expert appraisals of the Ministry’s documents and determine the priorities of its work.